Scott Gottlieb sailed through his FDA commissioner hearing

Scott Gottlieb, center, sailed through a confirmation hearing for Food and Drug Administration commissioner on Wednesday.

By

ThomasM. Burton

Scott Gottlieb, President Donald Trump’s nominee to run the Food and Drug Administration, emphasized in his confirmation hearing Wednesday his belief “in the gold standard of safety and efficacy” at the agency and said he hopes to expand approvals of generic drugs to lower U.S. prices.

Dr. Gottlieb, who was nominated in March, said he sees the need for new laws and FDA regulatory action to get complex-formulation drugs—like those used topically or with inhalers—more quickly approved as lower-cost generics. While he also said there are ways to speed up some clinical trials, “I think there are ways to modernize clinical studies without sacrificing the gold standard.”

His comments appeared aimed at reassuring Democrats, who have been critical of the nomination because of Dr. Gottlieb’s extensive financial ties to drug makers and his prolific, often conservative writings in which he has been critical FDA regulation, often saying the agency should move faster.

The tension between speed and a focus on safety has been at the center of political debates over the FDA’s future. That has especially been the case under the Trump Administration, since the president has said the FDA takes too long in approving drugs and medical devices.

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